User Guide - Medtronic Diabetes
Transcription
User Guide - Medtronic Diabetes
User Guide THERAPY MANAGEMENT SOFTWARE FOR DIABETES 6025179-026_a REF MMT-7335 © 2011 Medtronic MiniMed, Inc. All rights reserved. Paradigm® Veo™ is a trademark of Medtronic MiniMed, Inc. Paradigm®, Paradigm Link®, Guardian REAL-Time®, CareLink®, and Bolus Wizard® are registered trademarks of Medtronic MiniMed, Inc. BD Logic® is a registered trademark of Becton, Dickinson and Company. CONTOUR®, GLUCOFACTS®, ASCENSIA™, GLUCOMETER™, DEX™, ELITE™, and BREEZE® are trademarks of Bayer. LifeScan®, OneTouch® UltraLink™, OneTouch® Profile®, OneTouch® Ultra®, OneTouch® UltraSmart®, OneTouch® Basic®, OneTouch® FastTake®, OneTouch® SureStep®, OneTouch® UltraMini®, OneTouch® Ultra® 2, and OneTouch® UltraEasy® are trademarks of LifeScan, Inc. Optium Xceed™, Precision Xceed™, Precision Xtra®, Therasense FreeStyle®, FreeStyle® Flash, FreeStyle Mini®, and FreeStyle Papillon™ mini are trademarks of Abbott Laboratories, Inc. ACCU-CHEK® Active, ACCU-CHEK® Aviva, ACCU-CHEK® Compact, and ACCU-CHEK® Compact Plus are registered trademarks of a member of the Roche Group. Java™ is a trademark of Sun Microsystems, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. Adobe® and Acrobat® Reader® are registered trademarks of Adobe Systems, Incorporated. Contacts: Africa: Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help) Europe: Medtronic Europe S.A. Europe, Middle East and Africa Headquarters Tel: +41 (0) 21-802-7000 France: Medtronic France S.A.S. Tel: +33 (0) 1 55 38 17 00 Azerbaijan: Albatros Health Care Tel: +994 12 498 9537 Hellas: Medtronic Hellas S.A. Tel: +30 210677-9099 Bangladesh Sonargaon Healthcare Pvt Ltd. Mobile: (+91)-9903995417 or (+880)-1714217131 Hong Kong: Medtronic International Ltd. Tel: +852 2919-1300 To order supplies: +852 2919-1322 24-hour helpline: +852 2919-6441 Belarus: Badgin Ltd Tel: +375 (172) 665128 België/Belgique: N.V. Medtronic Belgium S.A. Tel: 0800-90805 Bosnia and Herzegovina Intermedical Tel: +387 33 202 183 Fax: +387 33 202 183 Brasil: Medtronic Comercial Ltda. Tel: +(11) 3707-3707 Bulgaria Interagro-90 Ltd Tel: +359 888 636 033 Canada: Medtronic of Canada Ltd. Tel: 1-800-284-4416 (toll free/sans-frais) China: Medtronic (Shanghai) Ltd. 24 Hour Help (Cell): +86 400-820-1981 24 Hour Help (Landline): +86 800-820-1981 Croatia Oktal Pharma Tel: +385 1 659 57 77 Fax: +385 1 659 57 01 India: India Medtronic Pvt. Ltd Tel: (+91)-80-22112245 / 32972359 Mobile: (+91)-9611633007 Indonesia: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Israel: Agentek Tel: +972 3649 3111 Italia: Medtronic Italia S.p.A. Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: Nº verde 24h: 800 712 712 Japan: Medtronic Japan Co. Ltd. Tel: +81-3-6430-2019 Kazakhstan: Medtronic Kazakhstan B.V. Tel: +77273110580 Latin America: Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244 Croatia Medtronic B.V. Tel: +385 1 488 11 20 Fax: +385 1 484 40 60 Latvija: Ravemma Ltd. Tel: +371 7273780 Danmark: Medtronic Danmark A/S Tel: +45 32 48 18 00 Macedonia: Kemofarm Tel: +389 2 260 36 03 Fax: +389 2 260 36 49 Deutschland: Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633 Eire: Accu-Science LTD. Tel: +353 45 433000 España: Medtronic Ibérica S.A. Tel: +34 91 625 05 42 Fax: +34 91 625 03 90 24 horas: +34 901 120 335 Magyarország: Medtronic Hungária Kft. Tel: +36 1 889 0688 Malaysia: Medtronic International Ltd. Tel: +603 7946 9000 Middle East and North Africa: Regional Office Tel: +961-1-370 670 Montenegro: Glosarij Tel: +382 20 642 495 Fax: +382 20 642 540 Nederland, Luxembourg: Medtronic B.V. Tel: +31 (0) 45-566-8291 Gratis: 0800-3422338 Slovenská republika: Medtronic Slovakia o.z. Tel: +421 26820 6986 Fax: +421 268 206 999 New Zealand: Medica Pacifica Phone: 64 9 414 0318 Free Phone: 0800 106 100 Sri Lanka Swiss Biogenics Ltd. Mobile: (+91)-9003077499 or (+94)-777256760 Norge: Medtronic Norge A/S Tel: +47 67 10 32 00 Fax: +47 67 10 32 10 Suomi: Medtronic Finland Oy Tel: +358 20 7281 200 Help line: +358 400 100 313 POCCИЯ: Medtronic B. V. Tel: +7 495 580 73 77 24h: 8-800-200-76-36 Sverige: Medtronic AB Tel: +46 8 568 585 10 Fax: +46 8 568 585 11 Philippines: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Taiwan: Medtronic-Taiwan Ltd. Tel: +886.2.2183.6068 Toll Free: +886.0800.005.285 Polska: Medtronic Poland Sp. Z.o.o. Tel: +48 22 465 6934 Thailand: Medtronic (Thailand) Ltd. Tel: +662 232 7400 Portugal: Medtronic Portugal Lda Tel: +351 21 7245100 Fax: +351 21 7245199 Turkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330 Puerto Rico: Medtronic Puerto Rico Tel: 787-753-5270 USA: Medtronic Diabetes Global Headquarters Tel: +1-800-826-2099 24 Hour HelpLine: +1-818-576-5555 To order supplies: +1-800-843-6687 Republic of Korea: Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600 Romania: Trustmed SRL Tel: +40 (0) 21 220 6477 Schweiz: Medtronic (Schweiz) AG Tel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199 Serbia Epsilon Tel: +381 11 311 5554 Fax: +381 11 311 5554 Singapore: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Slovenija: Zaloker & Zaloker d.o.o. Tel: +386 1 542 51 11 Fax: +386 1 542 43 32 Ukraine: Med EK Service Ltd. Tel: +380445457705 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Česká republika: Medtronic Czechia s.r.o. Tel: +420 233 059 401 Non-stop help line: +420 233 059 059 Contents Chapter 1 Chapter 2 1 Introduction 1 2 2 2 2 4 5 5 Features Security Related documents Assistance Supported devices Ordering How to use this guide User safety 7 Getting started 7 7 8 8 8 8 9 9 9 10 10 11 11 12 13 13 13 14 14 14 14 15 Before you begin Primary system tasks Navigating the system Opening CareLink Pro Workspaces Toolbar Patient tabs The Guide Me feature Turning Guide Me on and off Opening patient records Closing patient records Setting system preferences General preferences Patient profile preferences Choosing data fields Adding a custom field Changing the order of data fields Finalizing patient profile preferences Patient Lookup preferences Choosing data to display Changing the column order Finalizing patient lookup preferences CareLink Pro User Guide Contents v 15 15 17 17 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Report Generation preferences Choosing data to display Changing the column order Finalizing report generation preferences 18 Profile workspace 18 19 19 19 20 Before you begin Adding new profiles Editing patient profiles Deleting patient data from the system Linking to CareLink Personal 23 Hardware setup 23 Connecting devices 26 Devices workspace 26 27 27 29 31 32 Before you begin Adding a device Adding a Medtronic pump or Guardian monitor Adding a meter Making a device active or inactive Reading device data 35 Reports workspace 35 36 36 36 36 37 37 38 39 40 41 41 41 41 42 42 42 43 43 43 43 Before you begin Creating reports Opening the Reports workspace Selecting the reporting period Data calendar Selecting source data to include Checking for device data Getting additional device data Verifying report settings Selecting report types and inclusion dates Generating reports About reports Dashboard and Episode Summary Therapy Management Dashboard Episode Summary Adherence Report Sensor and Meter Overview Report Logbook Report Device Settings Snapshot Daily Detail Report Exporting data 45 System administration CareLink Pro User Guide Contents vi 45 46 46 46 46 47 47 Applying software updates Turning off automatic updates Manually checking for updates Backing up and restoring the database Backing up the database Restoring the database When the system is unavailable 48 Troubleshooting 48 48 49 49 50 50 50 General application use errors Not connected to the database Forgot the clinic password for CareLink Pro Device read errors Report creation errors Backup and restore errors Uninstalling the software Chapter 9 52 Icon table Appendix A 53 CSV data 53 54 55 Column data definitions More about CSV files exported by CareLink Pro If data is not displaying as expected Chapter 8 Glossary 56 Index 59 CareLink Pro User Guide Contents vii CareLink Pro User Guide Contents viii 1 Introduction Thank you for choosing Medtronic Diabetes as your partner in helping you and your patients better manage diabetes therapy. We believe you will benefit from CareLink® Pro software’s leading edge technology and simple, menu-driven user interface. CareLink Pro allows you to acquire, store, and report patient treatment and diagnostic data. You can also use it to access pump, meter, and sensor-based glucose data your patients have uploaded to CareLink® Personal, a web-based therapy management system that works with CareLink Pro. Features CareLink Pro is a diabetes therapy management software for a personal computer (PC). It includes these features: • Patient records can be created to store data gathered from a patient’s device as well as therapy data from his or her CareLink Personal account. • Data from insulin pumps, monitors, and blood glucose meters can be sent to the system, stored, and then used to generate reports. • As an option, it interfaces with the CareLink Personal system, allowing access to device data patients have stored there. This is ideal for creating current reports between office visits, and may make the need to read device data during office visits unnecessary. • Different treatment reports can be created from device data stored in the patient’s record. Reports facilitate answers to therapy concerns, such as patient adherence, patterns, and exceptions. • The system alerts you when software updates are available to be downloaded and installed. This ensures you have access to the latest features. • The Guide Me feature helps users who are new to CareLink Pro. It gives hints and tips about the tasks they are performing. • An integrated help system is available throughout the software to provide information on specific areas of interest. CareLink Pro User Guide Introduction 1 Security • CareLink Pro can be password protected. • Transmission of patient data from CareLink Personal is encrypted using industry-standard Secure Sockets Layer (SSL) technology. Related documents Each of these Medtronic MiniMed documents has device-specific information that is not covered in detail in this user guide. NOTE: For device-specific information on meters, see the instructions the manufacturer included with the meter. • Paradigm Insulin Pump User Guide • Guardian REAL-Time Monitor User Guide • Sensor Features User Guide • ComLink User Guide • CareLink USB User Guide Assistance If you need further help with this system, contact your local country representative. Access the following web site for international contact information: http://www.minimed.com/contact/international-locations Supported devices CareLink Pro gets data from the following devices. NOTE: Some devices supported by this software may not be available in all countries where this software is approved for use. Insulin pumps/Glucose monitors Medtronic MiniMed pumps: 508 Medtronic MiniMed Paradigm® series pumps: 511, 512, 712, 515, 715, 522, 722, 522K, 722K, Paradigm® Veo™ (554, 754) Guardian REAL-Time monitors: CSS-7100 CSS-7100K CareLink Pro User Guide Introduction 2 Manufacturer Linked meters: Bayer: LifeScan: BD: Bayer's Ascensia™ DEX™ family, including these compatible meters: Bayer's Ascensia™ ELITE™ family, including these compatible meters: Abbott: Roche: Blood glucose meters • Bayer's CONTOUR® LINK • BD Paradigm Link® Blood Glucose Monitor • CONTOUR® USB • Ascensia BREEZE® • BREEZE® 2 • CONTOUR® • OneTouch® UltraSmart® • OneTouch® Profile® • OneTouch® Ultra® • OneTouch® Basic® • OneTouch® FastTake® • OneTouch® SureStep® • OneTouch® Ultra® 2 • OneTouch® UltraMini® • OneTouch® UltraEasy® • Logic® • Ascensia™ DEX™ • Ascensia™ DEX™ 2 • Ascensia™ DEXTER-Z® II • Glucometer™ DEXTER-Z® • Ascensia™ ESPRIT® 2 • Glucometer™ ESPRIT® • Glucometer™ ESPRIT® 2 • Ascensia™ ELITE™ • Glucometer™ ELITE™ XL • FreeStyle® • FreeStyle® Lite® • FreeStyle® Freedom® • FreeStyle® Freedom Lite® • Precision Xtra® • TheraSense FreeStyle® • FreeStyle® Flash® • FreeStyle® Papillon™ mini • FreeStyle® Mini® • Optium Xceed™ • Precision Xceed™ • Accu-Chek® Aviva • Accu-Chek® CompactPlus • Accu-Chek® Compact • Accu-Chek® Active CareLink Pro User Guide Introduction 3 Communication devices CareLink® USB For use with the MiniMed Paradigm-series insulin pump and Guardian REAL-Time Monitor. Paradigm Link® Blood Glucose Monitor For use with a MiniMed Paradigm Pump or Guardian REAL-Time Monitor. (See the Paradigm Link® Blood Glucose Monitor User Guide for details about the required hardware.) ComLink For use with the MiniMed Paradigm Pump and Guardian REAL-Time Monitor. (See the ComLink User Guide for details about the required hardware.) Com-Station For use with the Medtronic MiniMed 508 Pump. (See the Com-Station User Guide for details about the required hardware.) For use with third-party blood glucose meters. Each meter manufacturer supplies a data communications cable. Data communications cable Note: If a meter manufacturer provides a USB cable instead of a serial cable for uploading data, you must install the software driver provided by that manufacturer. Also, check with the meter manufacturer to ensure that the USB driver is compatible with your operating system. Some USB drivers may not be available for 64bit operating systems. Equivalent devices When you add a device to the system, you select its make and model from a list. If a device make and model is not on the list, refer to the following table to find an equivalent one to use. If your patient uses one of these devices • Bayer's Ascensia™ DEX™ 2 • Bayer's Ascensia™ DEXTER-Z™ II • Bayer's Glucometer™ DEXTER-Z™ • Bayer's Ascensia™ ESPRIT® 2 • Bayer;s Glucometer™ ESPRIT® • Bayer's Glucometer™ ESPRIT® 2 Select this device Bayer's Ascensia™ DEX™ Bayer's Glucometer™ ELITE™ XL Bayer's Ascensia™ ELITE™ Precision Xceed™ Optium Xceed™ Ordering To order Medtronic Diabetes products, contact your local country representative. Access the following URL for international contact information: http://www.medtronicdiabetes.com/help/contact/locations.html NOTE: Meters can be ordered from their respective companies. CareLink Pro User Guide Introduction 4 How to use this guide NOTE: This user guide shows samples of the software screens. The screens of the actual software may be slightly different. Refer to the Glossary for definitions of terms and functions. The conventions used in this guide are defined in the following table. Term/style Meaning Click Press the left mouse button over an object on the screen to select it. Double-click Press the left mouse button twice over an object on the screen to open it. Right-click Press the right mouse button over an object on the screen to display another window or menu. Bold text Used for a button, screen name, field name, or menu option. For example: Patient > New Patient NOTE: Provides additional information for a procedure or step. CAUTION: Alerts you of a potential hazard which, if not avoided, may result in minor or moderate damage to the software program or equipment. WARNING: Notifies you of a potential hazard which, if not avoided, could result in death or a serious injury. It may also describe potential serious adverse reactions and safety hazards. User safety Indications for use The CareLink Pro system is intended for use as a tool to help manage diabetes. The purpose of this system is to take information transmitted from insulin pumps, glucose meters, and continuous glucose monitoring systems, and turn it into CareLink Pro reports. The reports provide information that can be used to identify trends and track daily activities—such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. Warnings • This system is intended to be used by a healthcare professional familiar with the management of diabetes. • System results are not intended to produce medical advice and should not be relied upon for such purpose. • This product should only be used with the supported devices listed in this document. (See Supported devices on page 2.) • Patients should be advised to monitor their blood glucose levels at least 4–6 times a day. • Patients should be advised not to make any changes to their treatment without consulting their healthcare professional. CareLink Pro User Guide Introduction 5 • Patients should be advised to make treatment decisions based on healthcare professional guidelines and meter BG results, not glucose sensor results. Contraindications This software should not be used with devices that are not listed in Supported devices on page 2. Nor should this product be used for the treatment of medical conditions other than diabetes. Before opening this software, close any of the following software that is currently running on your computer: • CGMS® System Solutions™ Software (7310) • Solutions® Pumps & Meters Software (7311) • Guardian® Solutions® Software (7315) • ParadigmPAL™ (7330) • CareLink® Personal software (7333) • Solutions® Software for CGMS®iPro (7319) CareLink Pro User Guide Introduction 6 2 Getting started The following information will guide you through starting the CareLink Pro software, opening and closing patient records, and setting preferences that apply to all patients in the system. Before you begin If this is the first time you are using CareLink Pro, you should be sure to set the General preferences (see General preferences on page 11). These preferences determine how certain items display in the software and in reports, and how you want the system to communicate with the Internet. Preferences can be set at any time. You may want to wait until you are familiar with the CareLink Pro software to set the other preferences. Primary system tasks The following table outlines the main tasks you will want to perform when first setting up and using CareLink Pro. It also tells you which part of this user guide discusses each task. Step Location Familiarize yourself with the CareLink Pro user interface. Navigating the system on page 8 Define the global system options your clinic will use. Setting system preferences on page 11 Create profiles for each of your patients. Adding new profiles on page 19 Link to your patients' CareLink Personal accounts. Linking to CareLink Personal on page 20 Add your patient's pump and meters to his or her profile. Adding a device on page 27 Read data from your patient's pump and meters. Reading device data on page 32 Set up and generate reports for each of your patients. Creating reports on page 36 Regularly back up the CareLink Pro database. Backing up the database on page 46 Update the CareLink Pro software. Applying software updates on page 45 CareLink Pro User Guide Getting started 7 Navigating the system Before working with the CareLink Pro software, you should get acquainted with the user interface. The user interface includes menus, a toolbar, a navigation bar, workspaces, and a Guide Me window. Opening CareLink Pro 1 Double-click the CareLink Pro icon on your computer desktop, or select Medtronic CareLink Pro from the Programs list on your Windows Start menu. If your clinic requires you to enter a password, the login screen is displayed. a. Type your password into the Password field. NOTE: Requiring a password is an optional feature that is set during the installation process. b. Click LOGIN. The startup screen is displayed. 2 To start a new patient record, click New Patient. To open a patient record from a list of patients in the system, click Open Patient. Workspaces If you have a patient’s record open, you can click one of the buttons on the navigation bar to display the corresponding workspace. Use these workspaces to enter or select information to perform CareLink Pro tasks for that patient. Profile: Allows you to maintain such patient information stored as name and date of birth. This workspace also allows you to link to a patient’s CareLink Personal account. Devices: Allows you to store information required to read a patient’s devices. Reports: Allows you to select parameters and choose reports to be generated for the patient. Until a profile is added and saved for a patient, only the Profile workspace is accessible for that patient. Until devices are added for a patient, only the Profile and Devices workspaces are accessible for that patient. Toolbar The CareLink Pro toolbar provides quick access to frequently used features. The toolbar contains the following buttons. CareLink Pro User Guide Getting started 8 Button Name Functionality Add Patient Opens a Profile workspace so you can add a new patient record to the system. Open Patient Opens the Patient Lookup table where you can choose an existing patient’s record to view. Guide Me Displays or hides the Guide Me window. Click for context-aware system hints. Patient tabs After you open a patient record, a tab is displayed along the toolbar with the patient’s name on it. When a tab is active, it means that patient record and workspace are active, and you can perform CareLink Pro tasks for the patient. To make a patient record active so that you can work with it, click on the tab for that patient. To close a patient record, click the Close button on the tab. The Guide Me feature A Guide Me feature is provided throughout CareLink Pro. It opens a window with context-aware hints and tips for actions you might take from the part of system that is active. Guide Me windows might also include >>learn more links. When clicked, these links take you to the relevant section in the online help for more details. The Guide Me feature is enabled by default. However, you can turn it off at any time. Turning Guide Me on and off To turn Guide Me on or off, do one of the following: • Click the Guide Me button. CareLink Pro User Guide Getting started 9 • Select Help > Guide Me. Opening patient records As many as six patient records can be open at one time. If you have not yet created any patient profiles, see Adding new profiles on page 19. 1 Select File > Open Patient, or click the Open Patient button. A patient list similar to the following is displayed. NOTE: If you receive a message that you have too many patient records open, click OK, close a record, and continue. 2 Locate the patient’s listing by typing some or all of his or her name in the Find a Patient field. When the patient’s listing is highlighted, click OPEN, double-click the listing, or press ENTER. You can also navigate the list by using the up and down arrows on your keyboard. The patient’s Devices (if devices have not yet been added) or Reports workspace is displayed. 3 To see the patient’s Profile workspace, click the Profile button on the navigation bar. Closing patient records 1 Make sure the patient record you want to close is active (the tab is highlighted). 2 Do one of the following: a. Select File > Close Patient. b. Click the Close button on the patient tab. c. Press Ctrl+F4. CareLink Pro User Guide Getting started 10 Setting system preferences These preferences apply to all patients in the system. For preferences that affect only individual patients, see Verifying report settings on page 39. Preferences are displayed in the following groups: • • General - Glucose units - Carbohydrate units - Communications - Troubleshooting Patient Profile - • Select and arrange data fields on patient profiles. Patient Lookup - Modify and change the order of fields displayed when you choose Open Patient to view a list of patients. • Report Generation - Choose the data fields you want to display when selecting Daily Detail report input from the Data table. General preferences Use the General tab to define how the software displays certain types of information and to establish your external communication preferences. 1 If it is not active already, click the General tab. 2 Select Tools > Options. The following window is displayed. 3 Click to select the option button for the value you want: CareLink Pro User Guide Getting started 11 - Glucose Units: mmol/L or mg/dL - Carbohydrate Units: grams or Exchanges a. If you selected Exchanges for Carbohydrate Units, type the appropriate number in the grams are equal to 1 Exchange field. 4 Click to select or clear the check box in the Chart Options > Overview Report section. If the check box is selected, the application will connect the BG readings on the Meter Glucose Overlay chart with lines. (This is a chart that appears in the Sensor and Meter Overview Report.) 5 For the following Communications preferences, click to select the check box (enable) or to clear the check box (disable): NOTE: Make sure you follow the guidelines of your clinic or IT department when setting communication preferences. - Automatically check for software updates: If selected, a notification will be sent to each system running CareLink Pro whenever a software update is available. The active user will then have the opportunity to download and install the updates. To prevent this from occurring and institute a controlled distribution of software updates, you can clear this check box. - Synchronize with Medtronic CareLink® Personal: If you want the system to automatically synchronize your patients' CareLink Personal data each time you open their profile, select this check box. If you clear this check box, you will have to manually synchronize the CareLink Personal data for each patient. 6 Click to select or clear the check box in the Troubleshooting section. If the check box is selected, the application will save a record of device reads for troubleshooting purposes. 7 Click OK to save the General preferences. Patient profile preferences This is a global setting that defines the content of your profiles. You can customize fields in the Profiles workspace to include information that is most important to your clinic. You can add or remove fields, create your own custom fields, and determine the order in which the fields will appear in the window. 1 Select Tools > Options. CareLink Pro User Guide Getting started 12 2 Click the Patient Profile tab. The following window is displayed. NOTE: Use the check boxes to choose the fields you want on the profile. Use the up and down arrows to put the fields in order. Choosing data fields 1 Use the check boxes to add the fields you want. NOTE: First and Last Name cannot be removed. 2 To remove a field from the profile, clear its check box. 3 To make a field required, select the check box in the Required column. Any field that is required must be filled in before a profile can be created. Adding a custom field 1 Select the check box to the left of an empty custom field. 2 Enter text to name the field (for example, Emergency Contact). This is the field name that will display on the patient profile. 3 To make the field required, select the check box in the Required column. NOTE: To remove a custom field from the profile, clear the check box next to the field(s) you want to remove. Changing the order of data fields Select the field you want to move, and click the up or down arrow to move it. (The arrows at the top and bottom move a field all the way to the top or bottom of the list.) CareLink Pro User Guide Getting started 13 Finalizing patient profile preferences When the Field Order list has all the fields you want in the correct order, click OK. Patient profiles now have the fields and field order you just selected. Patient Lookup preferences The Patient Lookup table is used to search for and open a patient record. The table includes every patient in your database and provides identifying information from the patient's profile. You have the option of customizing what information is displayed in this table and the order in which the columns appear. To customize the Patient Lookup table, complete the following steps: 1 Select Tools > Options. 2 Click the Patient Lookup tab. The following window is displayed. NOTE: Use the check boxes to choose the data you want on the Patient Lookup table. Use the up and down arrows to put the columns in order. Choosing data to display Use the check boxes to select the type of data you want to display or to clear data you do not want to display on the Patient Lookup table. Changing the column order To change the order of columns on the Patient Lookup table, select the column to move, and click the up or down arrows. (The arrows at the top and bottom move a data column all the way to the top or bottom of the list.) CareLink Pro User Guide Getting started 14 The data column at the top of the Column Display Order list will display in the first column of the Patient Lookup table. The data column at the bottom will be displayed in the last column of the table. Finalizing patient lookup preferences When the Column Display Order list has all the data you want in the correct order, click OK. The Patient Lookup table will now have the data and column order you just selected. Report Generation preferences The Data Table appears in the Select and Generate Reports window. This table is used during reporting. It contains daily information derived from your patient’s devices and, if applicable, his or her CareLink Personal software account. The data provided in this table helps you determine which days require a Daily Detail report. It also helps you decide which of the other reports you should run. Your clinic can customize the data that displays in this table, including the order in which it's presented, to reflect what is most relevant to your practice. NOTE: To see how these preferences apply to the Data Table during report creation, see Selecting report types and inclusion dates on page 40. 1 Select Tools > Options. 2 Click the Report Generation tab. The following window is displayed. Choosing data to display Use the check boxes to select the type of data you want to display or clear data you do not want to display on the Data Table. CareLink Pro User Guide Getting started 15 The following information is available for inclusion in the Data Table. Column Name Definition № of Meter Readings The amount of readings for the specified date that were recorded by the included devices. Meter Readings Average The average of the glucose readings recorded by the included devices. Sensor Duration The amount of time within the specified date for which sensor date was recorded. Values are -- (none), 0:05 - 24:00. Sensor Average The average of sensor readings recorded in the specified date. Highest Reading The highest glucose reading (derived from a sensor or meter) for the date. Lowest Reading The lowest glucose reading (derived from a sensor or meter) for the date. Avg AUC Below Target Avg Area Under the Curve below the patient's target range. Avg AUC Above Target Avg Area Under the Curve above the patient's target range. Total Carbs The sum of all carbohydrate amounts (rounded to the nearest gram or the nearest 0.1 exchange, depending on the unit of measure used) reported during the day through Bolus Wizard events or carbohydrate markers on the pump or Guardian monitor. Suspend Duration The amount of time the pump was suspended on the specified date. Values are -- (no data), 0:01 - 24:00. № of Rewinds The number of rewind events for the specified date. № of Primes (or Fills) The number of prime events (or fill events) recorded for the specified date. Prime (or Fill) Volume (U) The total volume of insulin used for prime events (or fill events) on the specified date. Total Insulin (U) The total volume of insulin given during the specified date, as recorded by the pump. Total Basal (U) The total volume of basal insulin given during the specified date (the total insulin given, less the sum of all boluses given). Total Bolus (U) The total volume of insulin given in boluses during the specified date, as recorded by the pump. Basal % Shows the ratio (in whole % values) of basal insulin to total insulin. Bolus % Shows the ratio (in whole % values) of bolus insulin to total insulin. № of Boluses The number of bolus events recorded for the specified date. Bolus Wizard Events The total number of bolus wizard events recorded on the specified date. Bolus Wizard Overrides The number of bolus wizard events where the amount of insulin delivered is different than the amount recommended. № of Meal Boluses The number of bolus wizard events with carbohydrate amounts greater than zero that were recorded on the specified date. CareLink Pro User Guide Getting started 16 Column Name Definition № of Correction Boluses The number of bolus wizard events with correction amounts greater than zero that were recorded on the specified date. № of Manual Boluses The number of bolus events recorded during the date, which were not bolus wizard events. Changing the column order To change the order of columns on the Data Table, select the column to move, and click the up or down arrow. (The top and bottom arrows move a data column all the way to the top or bottom of the list.) NOTE: Items at the top of the Column Order list will display in the first column of the Data Table. Items at the bottom will display in the last column of the Data Table. Finalizing report generation preferences When the Column Order list has all the data you want in the correct order, click OK. The Data Table will now have the data and column order you just selected. CareLink Pro User Guide Getting started 17 3 Profile workspace A profile is similar to the cover page of a medical chart. It stores patient data such as name and date of birth. A profile is required before device data can be gathered and used for therapy reports. The Profile workspace also allows you set up a link to a patient’s CareLink Personal account. Once the link is established, you can retrieve patient data stored on CareLink Personal anytime— without the need to have the patient present. Before you begin You may want to customize your patient profiles so they contain only the type of information you want to collect. To learn more, see Patient profile preferences on page 12. Also, a username and password is required when you set up the link to a patient’s CareLink Personal account. The patient must be present to supply this data. CareLink Pro User Guide Profile workspace 18 Adding new profiles Each time you add a patient to the CareLink Pro system, you must start by filling out a profile for him or her. 1 Select File > New Patient, or click the Add Patient button. The Profile workspace is displayed. NOTE: To add or change fields on the patient profile, click customize fields. See Patient profile preferences on page 12. 2 Fill in the fields in the Patient Profile section. 3 Click SAVE. The new patient profile is added to the CareLink Pro database. A message is displayed that confirms the profile was saved. Completing required fields 1 If a required field is not complete when you save a patient profile, a message is displayed next to that field. You will not be allowed to save the profile until you make an entry in the field. 2 Complete the field. 3 Click SAVE. 4 When the confirmation message displays, click OK. Editing patient profiles 1 Make sure the patient’s Profile workspace is open. 2 Click EDIT. 3 Edit the data in the Patient Profile section as needed. 4 Click SAVE. A message is displayed that confirms the profile was saved. Deleting patient data from the system 1 Make sure the patient’s Profile workspace is open. 2 Verify that this is the patient you want to delete. Deleting a patient profile also removes all of his or her data from the CareLink Pro database and cannot be undone. 3 Click >> delete patient record above the synchronization section of the profile. A message is displayed to alert you that all of the patient’s data will be erased when you delete the record. 4 Click Yes to delete the patient’s record. CareLink Pro User Guide Profile workspace 19 Linking to CareLink Personal If your patient permits it, you can set up a link to his or her CareLink Personal account. This Web-based tool allows patients to upload and store device-derived data and to run various therapy reports. After you link to the patient’s CareLink Personal account, you can retrieve the device data stored there. This is ideal for creating CareLink Pro therapy reports between office visits. It also reduces the need to read the patient’s device in the office. If patients do not yet have a CareLink Personal account, you can send them an e-mail inviting them to establish one. Linking to an existing account NOTE: The patient must be present to complete these steps. 1 Make sure you are connected to the Internet. 2 Open the patient’s Profile workspace. 3 Make sure all required fields in the Patient Profile section are filled in. 4 Click LINK TO EXISTING ACCOUNT. The CareLink Personal Log In screen is displayed. 5 Have the patient do the following: a. Type in his or her Username and Password. b. Click Sign In. A Grant Access page is displayed, based on the patient’s enrollment settings for language and region. 6 Have the patient do the following: a. Read the Terms of Use. b. Click to check the box next to I agree to the Terms of Use above... c. Click Grant Access. d. Let you know when the Thank You page is displayed. 7 If needed, print the Terms of Use for the patient by clicking the Print button. You are now linked to the patient's CareLink Personal account. Sending an e-mail invitation To send an e-mail inviting a patient to establish a CareLink Personal account, follow these steps: 1 Open the patient’s Profile workspace. 2 Make sure all required fields in the Patient Profile section are filled in. CareLink Pro User Guide Profile workspace 20 3 Click SEND E-MAIL INVITATION TO PATIENT. 4 Make sure Patient Name, E-mail Address, and Language are filled in correctly. 5 Click SEND. The patient’s profile status area confirms the e-mail was sent. Getting data from a linked account If you are linked to a patient’s CareLink Personal account, any new data from this account is automatically sent each time you open his or her patient profile in CareLink Pro. NOTE: To ensure this happens, go to Tools > Options > General, and make sure there is a check next to “Synchronize with CareLink Personal.” Follow these steps to get a patient’s CareLink Personal data any time after you have opened his or her patient profile: 1 Make sure the patient’s Profile workspace is open, and that you are connected to the Internet. 2 Select Tools > Synchronize Patient Data. The sync icon on the patient’s tab rotates. When the icon stops, the process is complete. NOTE: If the patient no longer wants to share his or her CareLink Personal data, a message displays to let you know. 3 Any additional data retrieved from CareLink Personal will show up in the patient’s reports. CareLink Pro User Guide Profile workspace 21 Unlinking a patient’s CareLink Personal account from CareLink Pro You can unlink a patient’s CareLink Personal account from CareLink Pro. This option is only available after a patient has been linked. It prevents CareLink Pro from continuing to retrieve data from the patient's CareLink Personal account. It does not affect the patient's personal usage of his or her CareLink Personal account. 1 Open the patient's record and access the Profile workspace. 2 Click UNLINK ACCOUNT. 3 Click Yes at the confirmation message. The patient's personal profile is no longer linked to CareLink Pro. The status is changed to Not linked, and the LINK TO EXISTING ACCOUNT and SEND EMAIL INVITATION TO PATIENT buttons are now displayed. CareLink Pro User Guide Profile workspace 22 4 Hardware setup To read data directly from a device, you must have the patient's device and any cables or communications devices required to transfer the data to your computer. Alternatively, if patients have uploaded their device data to their CareLink Personal account, you can obtain the data by linking to their account. To link to a patient's CareLink Personal account, see Linking to CareLink Personal on page 20. Connecting devices Review the overview diagram to get a general idea of how devices should be set up to communicate with the computer. The diagrams that follow illustrate specific aspects of device communication. For more details, follow the instructions CareLink Pro displays as you are reading devices. CareLink Pro User Guide Hardware setup 23 Overview of hardware setup The following example shows the CareLink USB being used to communicate between the pump and the computer. For a list of supported communication devices, see Supported devices on page 2. Serial and USB cable connection examples: CareLink Pro User Guide Hardware setup 24 Optional ComLink for use with the Paradigm series pump: Optional Com-Station for use with the Medtronic MiniMed 508 pump: CareLink Pro User Guide Hardware setup 25 5 Devices workspace Information that you will need to read a patient’s device, such as the manufacturer, model, and serial number, is stored in the Devices workspace. Thus, you do not have to supply it each time you read data from the device. Devices on the Devices workspace are stored in one of two lists—Active Devices or Inactive Devices. When you add a device, it is automatically placed on the Active Devices list. You can only read data from devices displayed in the Active Devices list. These will likely be the devices your patient currently uses. Other devices that belong to the patient, but are not currently used, can be stored in the Inactive Devices list. This keeps the information on file. These devices can be made active at any time. Before you begin Before you can open the Devices workspace for a patient, he or she must have a profile saved in the system. See Adding new profiles on page 19. CareLink Pro User Guide Devices workspace 26 To add a device or read data directly from it, the device must be communicating with the computer. See Connecting devices on page 23 to learn how to set up devices to communicate with the computer. Adding a device You can get data from the patient’s CareLink Personal account for a device not yet added. Such devices will automatically be added when data is synchronized between CareLink Personal and CareLink Pro. NOTE: There can only be one active pump per patient. Adding a new pump will move the existing one to the inactive list. Adding a Medtronic pump or Guardian monitor 1 Make sure the device you are adding is set up to communicate with the computer. (See Connecting devices on page 23 for connection steps.) 2 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 3 Click Devices 4 Click ADD DEVICE. 5 Select Medtronic Pump/Guardian. The Add Medtronic Pump/Guardian Wizard is to access the patient’s Devices workspace. displayed. NOTE: The pump model is listed on the back of the pump or on the pump status screen. 6 Select the option button to specify the device you are adding. If you selected the MiniMed 508 pump option, go to Step 9. CareLink Pro User Guide Devices workspace 27 7 Click NEXT. The Serial Number page is displayed. NOTE: An error message is displayed if you do not enter the correct serial number. Check the examples on this page, and verify that you are entering the correct characters from the back of the pump. If necessary, retype the six characters. 8 Use the examples on this page to help locate the six-character serial number on the device you are adding. (If you need more help in locating it, click >>learn more.) Type the six characters in the Device Serial Number field. 9 Click NEXT. A Communication Options page similar to the following is displayed. 10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm Link®, CareLink USB, or Com-Station connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB). CareLink Pro User Guide Devices workspace 28 11 Click NEXT. The Test Connection page similar to the following is displayed. 12 Follow any device instructions, and click TEST. A message displays to let you know if the connection was successful. If it was, go to the next step. NOTE: This Test does not read pump data, but verifies correct communications between the pump and the computer. If not, make sure the hardware between the device and the computer is connected properly. Also, click BACK on the pages of the wizard to make sure the device data you have entered is correct. 13 Click DONE. The device is added to the patient’s Active Devices list. Adding a meter 1 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 2 Make sure the meter you are adding is in communication with the computer. (See Connecting devices on page 23 for connection steps.) 3 Click the Devices button to access the patient’s Devices workspace. 4 Click the ADD DEVICE button. CareLink Pro User Guide Devices workspace 29 5 Select Blood Glucose Meter. The Add Blood Glucose Meter Wizard is displayed. 6 Click the option button to select the correct brand of meter. 7 Click NEXT. The Meter Model page is displayed (this page differs depending on the meter manufacturer). 8 Click to select the meter model you are adding. 9 Click NEXT. The Communication Options page is displayed. CareLink Pro User Guide Devices workspace 30 NOTE: Only those choices that are valid for the meter you are adding are available for selection. 10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm Link, or CareLink USB connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB). 11 Click NEXT. The Test Connection page is displayed. 12 Follow the instructions given for the meter, and click TEST. If you are adding Bayer's CONTOUR® USB meter, make sure that Bayer's GLUCOFACTS® software is closed. Check the Windows system tray, shown here. If you see the GLUCOFACTS icon, right-click the icon and select Exit. A message displays to let you know if the connection was successful. If it was, go to the next step. If not, make sure the hardware between the device and the computer is connected properly. Also, click BACK on the wizard to make sure the data you have entered is correct. 13 Click DONE. The meter is added to the patient’s Active Devices list. Making a device active or inactive Patient devices can be moved between the Active Devices list and the Inactive Devices list as needed. A device must be active in order to read data from it. You can have as many meters as you want on the Active Devices list, but only one pump. Make sure you want to inactivate the current active pump before you add a new one. CareLink Pro User Guide Devices workspace 31 Inactivating a device 1 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 2 Click the Devices button to access the patient’s Devices workspace. Devices may be listed under an equivalent device name. See Supported devices on page 2. 3 Click >> make this device inactive under the device you want to make inactive. The device moves to the Inactive Devices list. Re-activating a device 1 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 2 Click the Devices button. The patient’s Devices workspace is displayed. Devices may be listed under an equivalent device name. See Supported devices on page 2. 3 Click >> activate this device under the device you want to make active. The device moves to the Active Devices list. Deleting a device These steps will delete a device and its data from the Devices workspace and the CareLink Pro system: 1 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 2 Click the Devices button to access the patient’s Devices workspace. Devices may be listed under an equivalent device name. See Supported devices on page 2. 3 Make sure the device is on the Inactive Devices list. If it is not, click >> Inactivate this device under its current listing. 4 Click >> delete this device under the device you want to delete. A message is displayed to alert you that the device and all of its data will be removed from the patient’s record. 5 Click YES to delete the device. The device and its data is removed from the Devices workspace and from the CareLink Pro system. Data from this device is no longer available for use in reports. Reading device data One way to get device data is to link to the patient’s existing CareLink Personal account. (See Linking to CareLink Personal on page 20.) Another way is to read it directly from his or her device, as described here. Data from your patient’s device can be read by CareLink Pro if the device is on the Active Devices list and it is in communication with the computer. After you get this data, you can use it to create reports that help assess the patient’s therapy management. See About reports on page 41 for a brief description of the available reports. CareLink Pro can gather the following data from an insulin pump: • Various settings on the pump, such as the alert mode, the beep volume, and the time CareLink Pro User Guide Devices workspace 32 • Basal insulin amounts delivered • Bolus events and amounts delivered • Bolus Wizard entries • Priming amounts • Suspend periods • Sensor glucose readings over a period of time, on pumps with sensor capabilities The system can also gather data from a Guardian REAL-Time system including: • Sensor glucose (SG) readings • Sensor coefficient values • Sensor calibration factors • Meal markers • Insulin injections Additionally, various information stored in a blood glucose meter can be uploaded to the system during a device read. WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed. CAUTION: Do not use the pump remote when the pump is being read. If the pump battery is low, the pump will not send data to the PC. Replace the battery if the status indicates battery power is low. 1 Click the patient’s tab or double-click his or her name on the Patient Lookup table. 2 Make sure the patient’s device is in communication with the computer. (See Connecting devices on page 23.) 3 Click the Devices button to access the patient’s Devices workspace. Devices may be listed under an equivalent device name. See Supported devices on page 2. 4 Find the device you want to get data from on the Active Devices list, and make sure the Choose port data is correct. For pumps, click the Amount of Data drop-down menu and select how much pump data you want CareLink Pro to read. 5 Click the associated READ DEVICE button. 6 Follow device-specific instructions, and click OK. 7 CareLink Pro displays a progress bar that updates to show how much of the device read has been completed. If you click CANCEL as the device is being read, a message is displayed to alert you that cancelling the action may result in the loss of all of the data read so far. You will need to click the READ DEVICE button to restart the upload. CareLink Pro User Guide Devices workspace 33 - To cancel, click YES. - To continue reading device data, click NO. When the system finishes reading data from the device, you will see a message that confirms the device read is complete. 8 Click OK. - For pumps, follow the instructions for taking them out of suspend mode. If CareLink Pro is unable to get data from the device, see Troubleshooting for further guidance. CareLink Pro User Guide Devices workspace 34 6 Reports workspace CareLink Pro software provides a variety of reports to help you better manage your patients' diabetes treatment. The information contained in each report is based on data you obtain from a patient's devices and his or her CareLink Personal software account. Reports can be generated on screen, sent directly to a printer, or saved as TIFF or PDF files that you can attach to an Electronic Medical Record (EMR). You can generate several report types through a single operation. The data displayed through these reports is captured from the patient’s devices, from his or her CareLink Personal account, or from both. NOTE: More details about the report components, as well as sample reports are contained in the Report Reference Guide. You can access the Report Reference Guide through the CareLink Pro software by going to Help > View Report Reference Guide (PDF) and selecting the appropriate language. Before you begin If you have a period of time you want reflected in a report, you must have a patient’s device data for that time period. You may also need to have the patient’s device connected to the computer to get current data before running reports. CareLink Pro User Guide Reports workspace 35 Be sure to take a close look at the Verify Report Settings step before running a report. This is where you can fine-tune a report to capture the patient data you want. Creating reports The following sections will help you better understand the reports that are available to you and the process you use to generate them. If you are familiar with the reporting process and know what reports you would like to run, you can begin generating reports. Opening the Reports workspace Click the patient’s tab or click the Open Patient button and double-click the patient’s name. The Reports workspace is displayed. NOTE: To make sure you have the latest device data from the patient’s CareLink Personal account, click SYNC DATA. Selecting the reporting period 1 To change how much time is reflected in the report(s), click the Duration drop-down menu and select the amount of time. (The maximum duration is 12 weeks.) 2 From and through dates are automatically set, unless you choose the custom date range option. NOTE: If you select a date range longer than allowed, you get an error message. Adjust the duration or dates. If you want a custom date range, click the From or Through drop-down menus and select the desired month, date, or year. Data calendar The data calendar area of the Reports workspace shows a three-month window of reporting information. CareLink Pro User Guide Reports workspace 36 The blue bars represent device data. The orange bar represents the reporting period that you selected. Overlap in the device data and reporting period means you have data for some or all of the displayed reporting period. The data calendar area initially displays the most current three months. To see other months, click the arrow buttons on either end of the months. Selecting source data to include 1 If the patient uses a BG meter that links to his or her pump, click to choose one of the following options for reporting meter BG data: - In the pump: Advantages of this selection include that you only have to read data from the patient’s pump, BG readings are time stamped by the pump, and the readings are tied directly to any Bolus Wizard calculations used. A disadvantage is that if there are communication difficulties between the pump and the linked meter, BG readings during that time may not get reported. Also, for MiniMed Paradigm pumps prior to the 522/722, any BG readings from Bolus Wizard calculations that are not acted on do not get reported. - In the link meter(s): The advantage of this selection is that all readings stored in the linked meter are reported. The disadvantage is that to correlate meter and pump data, you must have made sure that the pump and meter clocks were synchronized with one another. You must also read data from the pump and the linked meter separately. 2 To add device data to reports, select the check box next to the relevant device. You cannot add devices that were excluded due to your selection in step 1. To change this, select the other linked meter option. 3 To exclude device data from reports, clear the check box next to the relevant device. You cannot clear check marks related to the option you selected in step 1. To change these, select the other linked meter option. Checking for device data 1 Look at the data calendar in the Reports workspace to see if the orange bar representing the reporting period overlaps with the blue bars representing device data. 2 If the bars overlap for the entire reporting period, you have data for your report(s). You can click NEXT and go to Verifying report settings on page 39. 3 If the bars do not overlap or there is not enough overlap, you have a few choices: CareLink Pro User Guide Reports workspace 37 - Adjust the reporting period. - Get additional device data. Getting additional device data 1 To get more data from a device, click the READ DEVICE button associated with the device. The Read Device bar is displayed. WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed. CAUTION: Do not use the pump remote when the pump is being read. If the pump battery is low, the pump will not send data to the PC. Replace the battery if the device status screen indicates battery power is low. 2 Verify that the data in the Choose port field is correct for this device. To change this setting, click the drop-down menu for the field and select a different setting. 3 Make sure the device is connected to your computer. 4 If the device is a pump, you can specify how much data to get from it. Click the Amount of Data drop-down menu and select an amount. NOTE: If you select All available data, the system reads all data in the pump. This overwrites any existing duplicate data in the system. 5 Click READ DEVICE. Be sure to read the message that is displayed carefully because it provides specific instructions for reading the pump. 6 Follow the instructions and click OK. The read device progress bar is displayed. You can choose to cancel the read at any time by clicking CANCEL. A message is displayed to confirm that the read is complete. 7 Click OK. Device data is now visible within the data calendar. 8 Click NEXT at the top of the Reports workspace. The Verify Report Settings step is displayed. This allows you to make sure the settings for this patient are correct before you run the report(s). CareLink Pro User Guide Reports workspace 38 Verifying report settings 1 Make sure the Glucose Target settings are at the desired values. Type in these values, or click the up or down arrows in the Low and High fields to raise or lower the values. NOTE: Meter reading markers (|| |) are displayed on the wake-up and bedtime timeline, as well as on the meal markers timeline. Because some of the reports are based on data found within defined meal times, wake-up, or bedtime hours, it is important that a patient's Bolus Wizard event and meter reading markers are grouped appropriately. 2 To add a new meal period, click ADD MEAL. To edit an existing meal period, click anywhere within one of the meal periods along the timeline. The Meal Period editor, located below the timeline, becomes active. NOTE: You can have as many as five meal periods. The defaults are breakfast, lunch, and dinner. 3 Enter text or click arrows to select the settings you want. If you only want to use these settings for this meal, clear the check box Use these parameters for all of this patient's meals. - Meal Name: name you want to assign to the meal period. - Meal Time Period: hours between which the meal occurs. - Pre-Meal BG Target (mmol/L or mg/dL): low and high ends of the patient’s beforemeal glucose target range. - Pre-Meal Analysis Period: time period that glucose will be analyzed prior to the start of a meal. The glucose readings captured during this time are used in a detailed report analysis. - Post-Meal BG Target (mmol/L or mg/dL): low and high ends of the patient’s post-meal glucose target range. - Post-Meal Analysis Period: time period that glucose will be analyzed after a meal. The glucose readings captured during this time are used in a detailed report analysis. You can change the length of an existing meal period or the wake-up and bedtime period by clicking on the start or end handles and dragging and dropping them along the timeline. NOTE: Meal periods cannot overlap, but start and end lines can border one another. Meal periods must be at least 60 minutes in length. 4 To use the settings from this meal for all of the patient’s other meals, make sure the check box next to Use these parameters for all of this patient’s meals is selected. 5 After you finish creating or editing a meal period, click SAVE. 6 To remove a meal period, click DELETE MEAL. Click DELETE when asked to confirm. 7 CareLink Pro can remember these settings for this patient the next time you run a report for him or her. To save them for this patient, click SAVE SETTINGS. 8 Click NEXT at the top of the Reports workspace. CareLink Pro User Guide Reports workspace 39 This is the Select and Generate Reports step of the process. It provides a list of report types as well as a Data Table that helps you choose to include or exclude certain days of data from the Daily Detail report(s). NOTE: To modify the Data Table display, click >> customize columns. See Report Generation preferences on page 15. 9 To print the screen, click the PRINT icon . Selecting report types and inclusion dates 1 Select the check box next to the report(s) you want to include in the report set. NOTE: The Dashboard/Episode Summary report check box will not be available if there are less than five days of sensor data and pump data in the selected time period or if the data in the time period is from a Guardian monitor. 2 If data has been read from a pump or Guardian monitor more than once during this reporting period, there may be multiple device snapshots: a. Make sure the check box is selected next to Device Settings Snapshot. b. Click the drop-down arrow and select a snapshot date and time. - Pump: Select a snapshot from the patient’s pump. - Guardian: Select a snapshot from the patient’s Guardian monitor. If either field is dimmed, there are no snapshots available during the reporting period. 3 Scroll though the Data Table to review the available Daily Detail report information. - You can sort the data in each column. Click the column heading to sort the data in ascending order. Click the heading again to sort the data in descending order. NOTE: If there is no data for a certain date, that date cannot be selected. 4 Select the check box in the Data Table rows for any date for which you want a Daily Detail report. - To include or exclude all Daily Detail report dates with one click, select the check box at the top of the Data Table check box column. CareLink Pro User Guide Reports workspace 40 Generating reports 1 After you verify your report selections, click GENERATE REPORTS at the top of the Reports workspace. A list of options is displayed. 2 Select an option to preview, print, or save the report(s). If you selected Preview, the Preview window is displayed. 3 Click the arrow buttons to navigate through multi-page reports. 4 Click one of the other buttons at the top of the Preview window to save or print the report(s). 5 To close this window, click the Close button in the upper right corner of the window. About reports This topic provides a description of each report. More details about the report components, as well as sample reports are contained in the Report Reference Guide. You can access the Report Reference Guide through the CareLink Pro software: 1 Help > View Report Reference Guide (PDF). 2 Select a language for the Report Reference Guide. The CareLink Pro reports share these common elements: • Report header — The report header contains identifying information, such as the name of the report, the patient's name, and the source of the data. • Carbohydrates and blood glucose levels — Within the graphs and charts, carbohydrate units are displayed in italics and blood glucose levels are displayed in bold. • Weekend data — Weekend days are in bold so you can easily identify them. • Legends — A legend of symbols appears at the bottom of each report. While a symbol may be used in multiple reports, the legends are unique to each report. Dashboard and Episode Summary The Dashboard and Episode Summary is a two-page report that is designed to provide a summary of a patient’s overall glycemic control for a selected time period. The first page of the report is called the Therapy Management Dashboard, and the second page is the Episode Summary. A description of each page is provided below. Therapy Management Dashboard The Therapy Management Dashboard allows you to see the overall level of glycemic control by time of day. The Dashboard page plots sensor glucose overlay traces and insulin delivery information on a daily graph. The Dashboard also shows overnight time period and periods CareLink Pro User Guide Reports workspace 41 around mealtimes, to help you assess glycemic control before and after meals. Using these graphs, you can visually discern key clinical patterns such as hyperglycemia, hypoglycemia and variability within the overall graphical view of glycemic control. The Dashboard includes a statistical analysis of hypoglycemic and hyperglycemic patterns recurring at particular times of the day. In addition, the Dashboard provides the ability to correlate glycemic control by time-of-day with key therapy modifiers, such as basal pattern, insulin absorption, insulin sensitivity, and carbohydrate ratios. This reduces the need to correlate events across multiple reports manually. Lastly, the Dashboard shows overall statistics of pump and sensor use. Episode Summary The Episode Summary page provides details of hypoglycemic and hyperglycemic episodes. It highlights the most critical episodes, and the frequency of correlated events of interest for further investigation. If applicable, the report enumerates the commonly known causes for hypoglycemic and hyperglycemic excursions and provides therapy considerations. Lastly, the Episode Summary provides overall observations regarding key behavioral or compliance measures related to insulin pump, CGM and BG meter usage. These observations may not be episode-related. Adherence Report The Adherence Report presents data that describes how insulin pumps and sensors are used and the patient’s behavior relevant to his or her therapy. It answers the question, “Was there enough data to provide an accurate picture of how the patient uses his or her insulin pump and sensor, if applicable.” It also answers the question, “Do patients adhere to the therapy as instructed?” It also indicates whether you may need to speak to your patients about the way they are managing their diabetes. Sensor and Meter Overview Report The Sensor and Meter Overview Report provides a graphical representation of the patient's daily sensor and meter-derived glucose levels and averages, including hourly breakdowns over 24 hours and as they relate to his or her meals and sleep patterns. Statistics on the patient's glucose readings and insulin usage are also included. A similar analysis of sensor data is generated as the first page of this report if sensor data is available. When no sensor data is available, the meter data analysis page will be generated as the first page. The final page(s) of the report shows the day-to-day level and quality of your patient’s glycemic, carbohydrate, and insulin control. Each page shows how that control varies during each day across the entire reporting period up to a 14 day maximum per page. CareLink Pro User Guide Reports workspace 42 Logbook Report The Logbook Report provides meter glucose, carbohydrate, and insulin data for each day in the reporting period. It provides a diary of events recorded hourly, as well as daily averages and totals. Each page contains up to 14 days. If the reporting period exceeds 14 days, extra pages are generated. Device Settings Snapshot The Device Settings Snapshot Report presents a snapshot of the settings for the patient's pump or Guardian REAL-Time monitor for a specific date and time. This can help you understand other reports or can simply document your patient's settings. The pump or monitor settings are recorded only when the device is read. If the device was not read during the reporting period, no settings will be available. Daily Detail Report The Daily Detail Report shows glucose data, carb amounts, and the patient’s insulin usage for the selected day. A separate report is generated for each day you select from the Data Table. The Daily Detail Report provides a detailed look at each day you select. It allows you to focus on a particular day if you feel something of interest to the patient’s therapy was occurring. Exporting data You can export device data that is acquired and stored by CareLink Pro. This gives you all of a patient’s device data to use for statistics or the creation of specialized reports or charts. The .csv file can be imported into Microsoft Excel or certain clinical statistics programs where you can further manipulate the data. The .csv file contains data recording the actions of the device. For example, it lists the recording of meter readings, the pump receiving the meter reading value, or change in basal rate. NOTE: This is an advanced feature and requires you to be familiar with the raw device data. It also requires proficiency with any software into which you import the .csv file. Follow these steps to use the CareLink Pro export feature: 1 Click the patient’s tab or click the Open Patient button and double click the patient’s name. 2 Make sure the Reports workspace is displayed. 3 Use the Duration or From/Through fields to set the dates and length of the report. The maximum duration you can select is 12 weeks. 4 Click the export selected data link. The Export Data to CSV File dialog box is displayed. 5 Navigate to the location where you want to store the .csv file on your computer. If you want to change the name of the file, type it into the File name box. CareLink Pro User Guide Reports workspace 43 6 Click SAVE. NOTE: For more information about the data displayed in CSV files, see the CSV data appendix. The .csv file is now saved on your computer in the location you selected. You can now choose to import it into any program that supports this file type. CareLink Pro User Guide Reports workspace 44 7 System administration It is important that you regularly back up the CareLink Pro database. The database stores all system data that has accumulated in your patient’s records, including profile information, devicederived data, and report settings. It is also important that you have the latest version of CareLink Pro. Updated versions are available periodically and may contain important enhancements. You can choose to search for updates or to be notified when they are available. Applying software updates There will be occasional updates to the CareLink Pro software. When notice of an update is displayed, take the following steps to download the latest software release. NOTE: The database should be backed up before a software update is applied. See Backing up the database on page 46. 1 Make sure an Internet connection is available and active on your computer. 2 The CareLink Pro Update message is displayed when there is an update to CareLink Pro. It gives you the option to download the update. 3 Click DOWNLOAD. (If you click CANCEL, the update notice will close. You can download the update at a later time.) A warning message is displayed that recommends backing up your database. 4 Click YES to create a backup of your database (see Backing up the database on page 46 for this procedure). Click NO if you have already backed up your data. A message is displayed to confirm that the new version of CareLink Pro has been downloaded. 5 To begin using the latest version of CareLink Pro, click YES to close and reopen the software application. Click NO if you would prefer to wait before restarting CareLink Pro. CareLink Pro User Guide System administration 45 Turning off automatic updates If you do not want to receive automatic notification of CareLink Pro updates, follow these steps: 1 Select Tools > Options. 2 Click the General tab. 3 Under the Communications section, clear the check box next to Automatically check for software updates. Manually checking for updates You can manually check for CareLink Pro updates at any time. NOTE: The database should be backed up before a software update is applied. See Backing up the database on page 46. 1 Make sure an Internet connection is available and active on your computer. 2 Select Tools > Check for Software Updates. 3 You will receive a message if no updates are currently available. If an update is available, a CareLink Pro Update message is displayed. 4 Follow the procedure in Applying software updates on page 45. Backing up and restoring the database It is a good idea to establish a regular schedule by which to perform database backups. This will help ensure that it is done regularly and will minimize the risk of data loss. If you are backing up or restoring the database, the system displays an alert message if there are active users of the software on other computers. Backing up the database The following steps let you back up the current database to the location you select. 1 Make sure all patient records are closed. 2 Select Tools > Backup Database. NOTE: Database backups can be saved on a network drive or to removable storage (such as a DVD, CD, or USB drive). 3 Navigate to the location on your computer where you want to save the backup file. If you want to change the name of the backup file, type it into the File name box. 4 Click Save. A progress bar is displayed while the database is saved. A message is displayed when the backup is complete. 5 Click OK to close the message. CareLink Pro User Guide System administration 46 Restoring the database The current database may need to be replaced if it can no longer be accessed or used. The more current your backup, the less data you will lose if you replace the database. CAUTION: When you restore the database with a backup copy, you lose all the new data created in the current database since the selected backup copy was made. The following steps let you select a backup copy to replace the current database. 1 Make sure all patient records are closed. 2 Select Tools > Restore Database. 3 Select the backup file you want to use to replace the current database (usually the most recent). 4 Click Open. A warning message is displayed to remind you about the data that may be lost if you continue the database restore. 5 To continue, click OK. A progress bar is displayed while the database is being restored. A message is displayed when the database is restored. 6 Click OK to close the message. When the system is unavailable If you attempt to start the system while another user is performing a backup or restore, you will receive a message notifying you that the system is not available. You will not be able to access the system until the task is complete. Do one of the following: • Wait for the process to complete and for the system to become available. • Click CANCEL to exit and try again later. CareLink Pro User Guide System administration 47 8 Troubleshooting This topic is designed to help you solve issues that may occur while using CareLink Pro software. It also contains instructions for uninstalling the CareLink Pro software if necessary. General application use errors If you try to download a software upgrade over the Internet, you may receive the message that you do not have sufficient privileges to do so. You must have administrative privileges to download CareLink Pro software upgrades. 1 Close the CareLink Pro software application, and restart your computer system. 2 Have someone with administrative privileges log in to the computer. 3 Follow the instructions in Applying software updates on page 45. Not connected to the database An error message stating that you are not connected to the database indicates one of the following: • The database has been moved. The database must be located in the same place that was selected during installation of the CareLink Pro software. If it has been moved, it must be moved back to the location selected during installation. • You are not connected to the network drive where the database is located. If the database is located on a network drive, the network may occasionally experience problems that prevent you from accessing the drive. Contact your computer support department for help in reconnecting to the network drive where the database is located. CareLink Pro User Guide Troubleshooting 48 Forgot the clinic password for CareLink Pro If no one can remember the password your clinic uses to log in to CareLink Pro, the CareLink Pro software must be re-installed and a new database created. After you re-install the software, you will not be able to access any patient information that was in the previous database. Store the password that you created during the new installation somewhere in the office so that you will not lose future data. Device read errors Error Explanation The selected serial port could not be opened. Another operation might be in progress on that port. Please wait until the port is available, or select another port. Please verify that the com port selected is not in use by another program, or select a different port. Try rebooting the computer you are using and then try the device read again. The hardware (such as the cable) connected to the port or the port itself may be bad. Connect the hardware to another port and try the device read again to help determine the problem. Auto Detect could not find the device on any available port. Please check the cable connection, device battery & status and try again, or try specifying a serial port. Check the connection between the cable and the PC, and verify that the device battery status is fine. If so, try specifying the PC serial port to which the cable is connected, rather than selecting Auto Detect. Device not found at selected serial port. Please check the cable connection, device battery & status and try again, try selecting a different port, or try to Auto Detect the device. Check the connection between the cable and the PC, and verify that the device battery status is fine. If so, try either selecting a different PC serial port number, or choose the Auto Detect option. Unable to communicate with the device. Please ensure you’ve attached and selected the correct device, check the cable connection, device battery and status, and try again. Verify all settings selected for the device read, including device name, serial number, and type of connection. Also check to make sure that the device, cable, and PC are connected properly. Verify the battery and alarm status of the device are okay. Try the read again. Unexpected response... retrying (n%) An unexpected value was read from the device. The system retries communication until you cancel or communication succeeds. The link device was found, but the device (<serial #>) is not responding. Please verify the device’s serial number, place the device closer to the link device to minimize signal interference, check device battery and status. Verify that the correct serial number was entered. If not, re-enter the correct serial number. If the serial number is correct, try moving the link device closer to the communication device. Move the link device and communication device away from possible interference (such as other RF devices). Check the device's battery strength and if uploading an insulin pump, check the pump delivery status. This pump is delivering a temp basal. Please cancel the temp basal or wait until it completes, and then try again. The pump you are attempting to read is delivering a Temp basal. Either wait until the Temp basal completes to read the pump, or cancel the Temp basal and then read the pump. This device has active errors or alarms. Please clear the alarms and try again. There are active alarms on the pump that prevent it from being read. Read the alarm instructions for clearing the alarm. Clear the alarm and try the pump read again. This pump is delivering a bolus. Please cancel the bolus or wait until it completes, and then try again. The pump you are attempting to read is delivering a bolus. Either wait until the bolus completes to read the pump, or cancel the bolus and then read the pump. The device returned invalid entries; all data read will be discarded. Contact your local country representative (see Assistance on page 2). CareLink Pro User Guide Troubleshooting 49 Report creation errors Multiple data entries for the same date If multiple data entries exist for the same date and time for the same device, the system considers this to be a conflict that it cannot resolve. Reports created using this device data will omit the portion of data that overlaps. You can try to adjust the reporting period to miss the overlapping data. Or, you can remove the device from the system and then add it back again to clear the previous readings. System is going to ignore data If the time on a device has been changed causing overlaps or gaps in data of three hours or longer, the system does not include that portion of data when creating reports. Backup and restore errors The database cannot be locked This means that you are using the system in a multi-user environment, and other users are logged in. The system will not allow a database backup to be performed while other users are potentially performing tasks that may affect the database. Once all other users exit CareLink Pro, you can perform the database backup. A database backup or restore is not completing Other users cannot log in and the backup or restore cannot complete. Please contact your local country representative (see Assistance on page 2). A restore database fails The database backup file you are attempting to use in the restore process is corrupt. Try restoring with a different backup file. Uninstalling the software If you need to uninstall CareLink Pro, complete the following steps: 1 Open the Control Panel through your Windows Start menu. 2 Select Add or Remove Programs.The Windows Add or Remove Programs window is displayed. 3 Scroll down to Medtronic CareLink Pro and click on it. 4 Click Remove. The Install Shield Wizard is displayed. 5 Click Next. A message is displayed asking you to confirm that you want to remove the application. CareLink Pro User Guide Troubleshooting 50 6 Click Yes. The uninstall program runs and removes the program and all of its files from your computer. When it is done, a message displays on the wizard screen confirming the uninstall. 7 Click Finish. CareLink Pro User Guide Troubleshooting 51 9 Icon table The icons and symbols on the packaging labels and the equipment are described in the following table: Description One per container/package Icon (1X) CD enclosed Consult instructions for use Date of manufacture (Year) Catalogue number Conformité Européene (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC. CareLink Pro User Guide Icon table 52 A CSV data When you export report data from the CareLink Pro software, it is exported into a .csv file. This file can then be imported into a spreadsheet application, such as Microsoft Excel. See the CSV file column definitions for a complete listing of the data that can be contained in a CSV file. The CSV file contains the name and Patient ID for the patient, the reporting period, and identifies each device included in the report. Column data definitions Column heading Definition Index The order in which data was recorded in the device. Date The date data was recorded in the device. Time The time data was recorded in the device. New Device Time The new date and time if this was changed in the device. BG Reading (mmol/L or mg/dL) The blood glucose reading recorded by the meter, Guardian, or pump. If the data is from a pump or Guardian, this column reflects manual BGs and BGs received from a Link meter. Linked BG Meter ID The serial number for the meter that sent a particular blood glucose reading to the device. Basal Rate (U/h) The active basal insulin delivery rate in units per hour. Temp Basal Amount If a temp basal was applied on the pump, this value is the temp basal amount. Temp Basal Type The type of temporary basal adjustment (insulin rate or percent of basal). Temp Basal Duration (m) The length of time in minutes for the temporary basal insulin delivery (see type above). Bolus Type The bolus insulin delivery type [Normal, Square, Dual (normal part), or Dual (square part)]. Bolus Volume Selected (U) The number of units of insulin selected to be delivered during the bolus insulin delivery. CareLink Pro User Guide CSV data 53 Column heading Definition Bolus Volume Delivered (U) The number of insulin units actually delivered during the bolus insulin delivery. Programmed Bolus Duration (h) Duration of a square bolus or the square portion of a dual wave bolus. Prime Type Manual or fixed. Manual is used just after a rewind, to fill the infusion set tubing with insulin before inserting it. Fixed is used after infusion set insertion to fill the soft cannula with insulin after removing the introducer needle. Prime Volume Delivered (U) The number of units of insulin actually delivered for the prime. Alarm The name of the alarm that occurred. Suspend Identifies the suspended state of the pump. Rewind Date and time the device was rewound. BWZ Estimate (U) The bolus insulin estimate calculated by the Bolus Wizard feature on the Paradigm pump. BWZ Target High BG (mmol/L or mg/dL) The setting for the high end of the blood glucose target range, used by the Bolus Wizard feature. BWZ Target Low BG (mmol/L or mg/dL) The setting for the low end of the the blood glucose target range, used by the Bolus Wizard feature. BWZ Carb Ratio The setting for insulin-to-carbohydrate ratio. If grams are used as the units, the ratio is the number of grams covered by one unit of insulin. If exchanges are used for units, the ratio is the number of insulin units used to cover one exchange. BWZ Insulin Sensitivity The setting for insulin sensitivity. Insulin sensitivity is the amount the blood glucose level is reduced by one unit of insulin. This is used by the Bolus Wizard feature. BWZ Carb Input Amount of carbohydrates entered into the Bolus Wizard and used to estimate a bolus. BWZ BG Input (mmol/L or mg/dL) Blood glucose reading when entered into the Bolus Wizard and used to estimate a bolus. BWZ Correction Estimate (U) Units of bolus insulin to give for blood glucose level correction, as calculated by the Bolus Wizard feature. BWZ Food Estimate (U) The estimated units of bolus insulin to give to cover the expected amount of carbohydrate consumption, as calculated through the Bolus Wizard feature. BWZ Active Insulin (U) The amount of active insulin calculated to be left in the body from prior bolus insulin deliveries when determining the estimated bolus amount through the Bolus Wizard feature. Sensor Calibration BG (mmol/L or mg/dL) The BG value used for calibrating the sensor in mmol/L or mg/dL. Sensor Glucose (mmol/L or mg/dL) The sensor glucose value. ISIG value Input signals (ISIG), being read from the sensor, measured in nanoamperes (nA). More about CSV files exported by CareLink Pro The title at the top of the CSV file includes the following: CareLink Pro User Guide CSV data 54 • patient’s name • a list of selected devices and their serial numbers • selected date range Each block of columns has a title that includes the following: • name of the device to which the block of data applies • serial number of that device If data is not displaying as expected A number of different factors can cause the CSV data to display differently than expected. • Date or time changes on the device can change the sequence or cause records outside the selected date range to be shown. • If there is a large gap between device reads, data for that device may be displayed in multiple blocks. CareLink Pro User Guide CSV data 55 Glossary A1C - Glycosylated hemoglobin A1C Test - Hemoglobin A1C test, used to interpret blood glucose level over a period of time. Area Under the Curve (AUC) - Indicates the amount in high and low excursions as determined by preset values. Excursion data indicates the frequency of highs or lows. AUC indicates the magnitude of events by showing how far out of range and for how long. Audio bolus - The pump can be programmed so the user hears a beep when he or she selects a bolus insulin amount (0.5 or 1.0 units) to be delivered. This is useful for situations when it is difficult to see the buttons on the pump. Basal insulin - An hourly, continuous infusion of insulin delivered automatically by an insulin pump based on preprogrammed profiles and personalized rates set in the pump. The pump delivers a daily infusion of insulin that typically covers background insulin needs during periods of fasting (such as overnight and between meals). Basal patterns - Users can program up to three different basal rate patterns into their pump for the delivery of basal insulin: Standard, A, and B. For each pattern, there is the option of setting up to 48 basal rates. Basal profile - A basal rate with a start and stop time. Users can program several different profiles into their pump, each with a different basal rate, during a 24-hour period of time to achieve better glucose control. Basal rate - The pump setting that provides a continuous infusion of insulin to keep the blood glucose stable between meals and during the night. Basal insulin mimics pancreatic insulin delivery—which meets all the body's non-food related insulin needs. BG - Abbreviation for blood glucose. Bolus insulin - A dose of insulin given to cover an expected rise in blood glucose (such as the rise after a meal or a snack) or to lower a high blood glucose down to target range. Cal Reminder - The pump will trigger a Meter BG By HH:MM alert automatically every 12 hours, signaling that the current calibration value is no longer valid. The value of the Cal Reminder is the amount of time before the current calibration value expires by which the user wants to be reminded to calibrate. For example, if the Cal Reminder is set to 2 hours, the Meter BG By HH:MM alert will occur 2 hours before calibration is required. Carb ratio (carbohydrate ratio) - The amount of carbohydrates covered by one unit of insulin. (Also see exch ratio.) Carb units - The food entry when using the Bolus Wizard. Entered as (carbohydrate) grams or exchanges. CareLink® Personal - An online service that allows management of diabetes data via the Internet. CH - Carbohydrate CareLink Pro User Guide Glossary 56 ComLink - A radio frequency (RF) transceiver device used to download Paradigm pump data to the computer. Com-Station - A device used to download MiniMed 508 pump and pass-through third-party meter data to the computer. Correction bolus - The amount of insulin needed to return a high blood glucose level back down to target range. Correction bolus factor - How much 1.0 unit of insulin will lower your blood glucose. This factor is used to calculate a correction bolus amount when your blood sugar is high. (BG level) - (BG target) = X. X ÷ (correction bolus factor) = correction bolus amount Dual Wave® bolus - Combination of a Normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time. Easy Bolus™ - Method of delivery for a Normal bolus by using the Easy Bolus button on the pump. Exch ratio (exchange ratio) - The amount of insulin required to cover one (1) carbohydrate exchange. (Also see carb ratio.) Express bolus - Method of delivery for any bolus type using the express bolus button on the pump. Food bolus - A dose of insulin given to cover the expected rise in blood glucose that occurs after eating. HbA1c - Glycosylated hemoglobin. HbA1c Test - Hemoglobin A1C test, used to interpret blood glucose control or average of levels over a 2- to 3-month period of time. High Glucose - The pump will alarm if the sensor indicates that the user’s sensor glucose is at or above this value. You have the option to turn this feature on or off. Hyperglycemic - Elevated blood glucose as seen by monitoring blood glucose levels with or without any or all of the following symptoms: nausea, vomiting, blurred vision, headache, gastric distress, frequent urination of large amounts, and lethargy. Hypoglycemic - Low blood glucose as seen by monitoring blood glucose levels, with or without any or all of the following symptoms: excessive hunger, shaking or tremors, perspiration, dancing visions, light-headedness, headache, blurred speech, sudden mood swings, or personality change. Infusion set - The apparatus used for inserting and securing a cannula below the skin and transporting insulin to the insertion site via tubing from the pump. Insulin concentration - The strength or type of insulin the doctor has prescribed for the user. This affects the rate of insulin the pump delivers. If the user’s insulin concentration changes, the basal patterns and the maximum basal and bolus rates must be reprogrammed in the pump. Insulin sensitivity - The amount of mmol/L (or mg/dL) that your blood glucose (BG) level is reduced by one unit of insulin. (Bolus Wizard data.) ISIG - Sensor values that indicate whether the transmitter electronics in a sensor-augmented system are working properly. If you see an ISIG value that is less than 24.00 nA or more than 29.00 nA, call for product assistance. It may be time to replace your transmitter. Ketone test - Ketone is a waste product that is produced when the body is forced to burn body fat instead of glucose for energy. It may be a sign of lack of insulin in the body. The Ketone test measures the amount of ketone concentrated in the blood or urine. Link (1) To turn on and setup the meter option that allows the pump to receive BG readings from a meter that communicates with your pump. (2) It is also used in this system to refer to hypertext links. When clicked on, hypertext links take you to another place in the system or to another Web site. Low Glucose - The pump will alarm if the sensor indicates that the user’s sensor glucose is at or below this value. You have the option to turn this feature on or off. CareLink Pro User Guide Glossary 57 Low reservoir warning - Programmable warning that notifies you with an alert when either a specified number of units remain in the reservoir of your pump, or a specified amount of time remains before the reservoir will be empty. Manual bolus - Optional item available in the BOLUS MENU when the Bolus Wizard is active. One method of programming a bolus without the Bolus Wizard. Max basal insulin - The maximum amount of basal insulin that the pump will deliver at one time. (Set by the user.) Max bolus - The maximum amount of bolus insulin that the pump will deliver at one time. (Set by the user.) Mean Absolute Difference % (MAD%) - Represents the level of accuracy in calibration of the sensor to BG meter readings. The lower this number, the greater the calibration accuracy. MAD % is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings, dividing by the BG meter reading, and then averaging across all pairs. Meter - A medical device for determining the approximate concentration of glucose in the blood. A small drop of blood is placed on a disposable test strip, which the meter reads and uses to calculate the blood glucose level. The meter then displays the level in mmol/L or mg/dL. Meter option - Feature that allows the pump to receive BG readings from a linked BG meter. Normal bolus - An immediate delivery of a specified unit amount of insulin. Pattern feature - Extended pump feature that allows you to program optional basals (Pattern A, Pattern B) that support activities or glucose patterns that are not a part of your day-to-day routine, but are usual in your lifestyle. Such activities could be a sport that you do once a week, a change in your sleep pattern over the weekend, or hormonal changes during a menstrual cycle. Pattern, standard - Your normal basal that supports your usual day-to-day activity. When the Patterns feature is off, the pump uses your standard (basal) pattern. RF - Radio frequency (RF). Square Wave® bolus - Bolus delivered evenly over a specified time period (30 minutes to 8 hours). Square Wave portion - (Sq) The second part of a Dual Wave bolus. The Square Wave portion delivers evenly over a period of time after the NOW portion delivers. Step - Measurement of insulin that you set and use for Easy Bolus delivery. Suspend - Function on the pump that stops all insulin delivery. Any current bolus and/or prime deliveries are canceled. The basal delivery is paused until restarted. Temp - Temporary. Temp basal (tmp basal) - Temporary, one-time basal insulin with a specified amount and duration. Used to support insulin needs for special activities or conditions that are not part of the normal daily routine. Transmtr ID - The serial number of the transmitter currently in use. Upload - The process for transferring pump or meter data to the CareLink® Personal server. CareLink Pro User Guide Glossary 58 Index A about reports 41 Adherence report 42 Daily Detail report 43 Dashboard and Episode Summary 41 Device Settings Snapshot 43 Logbook report 43 Sensor & Meter Overview report 42 activating devices 32 adding a device to the system 27 adding a Guardian monitor to the system 27 adding a meter to the system 29 equivalent meter names to choose 4 adding a patient 19 adding a patient’s device to the system Guardian monitor 27 meters 29 pumps 27 adding a pump to the system 27 Adherence report about 42 B backing up the database 46 basic CareLink Pro tasks 7 Bayer Ascensia® DEX® devices equivalent to 4 Bayer Ascensia ELITE™ XL devices equivalent to 4 buttons on the toolbar 8 C cables for connecting devices to computer serial 24 USB 24 CareLink Personal getting data 21 linking to an account 20 email invitation 20 existing account 20 checking for device data for reports 37 closing patient profiles 10 ComLink 4, 25 communication devices supported by CareLink Pro 4 communications devices supported 2 Com-Station 4 connecting devices to computer 23 cables 24 computer connections 24 serial 24 USB 24 meter options 23 optional components 25 ComLink 25 connecting devices to your computer computer connections 24 serial 24 USB 24 overview 24 contraindications 5 copying the database for backup 46 creating patient profiles 19 creating reports 36 checking for device data 37 getting new device data 38 making your own report 43 opening the reports workspace 36 previewing 41 printing 41 saving 41 selecting devices 37 selecting report types and inclusion dates 40 selecting the reporting period 36 verifying report settings 39 CSV files exporting device data to 43 CareLink Pro User Guide Index 59 D Daily Detail report about 43 Dashboard and Episode Summary about 41 data communications cable 4 data communications cable supported 4 database copying for backup 46 restoring with backup copy 47 deleting a patient’s device from the system 32 device data getting data from CareLink Personal 21 getting it from a patient’s device 32 linking to CareLink Personal 20 email invitation 20 existing account 20 Device Settings Snapshot about 43 devices activating 32 adding to the system 27, 29 Guardian monitor 27 meters 29 pumps 27 checking for data for reports 37 connecting to computer 23, 24, 25 computer connections, serial 24 optional components, ComLink 25 connecting to your computer 24 computer connections, serial 24 overview 24 deleting 32 deleting from the system 32 exporting data 43 getting data 32, 38 new data for reports 38 inactivating 32 ordering 4 selecting for reports 37 storing in the system 31, 32 inactivating 32 making active 32 supported 2, 3, 4 ComLink 4 Com-Station 4 glucose meters 3 insulin pumps 2 meter data communications cable 4 supported by CareLink Pro 2 devices workspace adding devices 27, 29 Guardian monitor 27 meters 29 pumps 27 deleting devices 32 getting device data 32 storing devices 31, 32 inactivating 32 making active 32 documents related to this user guide 2 downloading software updates 45 E editing patient profiles 19 email invitation to set up a CareLink Personal account 20 equivalent devices alternative meter names to choose 4 existing CareLink Personal account linking to 20 exporting device data 43 F features of CareLink Pro 1 security 2 G general preferences setting 11 generating reports 41 previewing 41 printing 41 saving 41 getting a patient’s device data 32 getting device data from CareLink Personal 21 linking to CareLink Personal 20 email invitation 20 existing account 20 new data for reports 38 global system preferences setting 11, 12, 13, 14, 15, 17 general preferences 11 open patient preferences, choosing data 14 patient lookup preferences 14 patient lookup preferences, changing column order 14 patient profile preferences 12 patient profile preferences, adding a custom field 13 patient profile preferences, changing field order 13 patient profile preferences, choosing data fields 13 report generation preferences, changing column order 17 report generation preferences, choosing data 15 understanding 11 glucose meters supported 2 glucose meters supported by CareLink Pro 3 Guardian monitor adding to the system 27 CareLink Pro User Guide Index 60 Guardian monitors inactivating 32 Guide Me feature 9 H hardware connections 23 cables 24 computer connections 24 serial 24 USB 24 meter options 23 optional components 25 ComLink 25 overview 24 USB 24 HelpLine, contacting 2 how to use this user guide 5 I icons 52 inactivating devices 32 inclusion dates selecting for reports 40 indications for use 5 insulin pumps supported 2 insulin pumps supported by CareLink Pro 2 K key features of CareLink Pro 1 L linking to CareLink Personal accounts 20 email invitation 20 existing account 20 getting data 21 Logbook report about 43 logging in to CareLink Pro 8 M Medtronic MiniMed products ordering 4 meter cable 4 meter data communications cable supported 4 meter name equivalent devices 4 meters activating 32 adding to the system 29 connecting to computer 23, 24, 25 computer connections, serial 24 computer connections, USB 24 optional components, ComLink 25 connecting to your computer 24 computer connections, serial 24 computer connections, USB 24 deleting 32 getting data 32 inactivating 32 options for communicating with computer 23 ordering 4 supported 3 N navigating workspaces 8 navigating the CareLink Pro GUI 8 navigation bar workspaces 8 notification of software updates 45 O online device data getting the data 21 linking to CareLink Personal 20 email invitation 20 existing account 20 open patient preferences setting 14 choosing data 14 opening reports workspace 36 opening CareLink Pro 8 entering your password 8 logging in 8 opening patient profiles 10 optional devices for communicating with computer 25 ordering devices 4 Medtronic MiniMed products 4 meters 4 Paradigm Link 4 pumps 4 overview of CareLink Pro 1 P Paradigm Link ordering 4 password entering for CareLink Pro 8 patient lookup preferences setting 14 changing column order 14 CareLink Pro User Guide Index 61 patient profile preferences setting 12, 13 adding a custom field 13 changing field order 13 choosing data fields 13 patient profiles closing 10 creating 19 editing 19 opening 10 PC connecting devices 23, 24 computer connections, serial 24 computer connections, USB 24 connecting devices to it 24, 25 computer connections, serial 24 computer connections, USB 24 optional components, ComLink 25 overview 24 preferences system 11, 12, 13, 14, 15, 17 setting 11 setting, general preferences 11 setting, open patient preferences, choosing data 14 setting, patient lookup preferences 14 setting, patient lookup preferences, changing column order 14 setting, patient profile preferences 12 setting, patient profile preferences, adding a custom field 13 setting, patient profile preferences, changing field order 13 setting, patient profile preferences, choosing data fields 13 setting, report generation preferences 15 setting, report generation preferences, changing column order 17 setting, report generation preferences, choosing data 15 understanding 11 previewing reports 41 primary CareLink Pro tasks 7 printing reports 41 product overview 1 profiles closing 10 creating 19 editing 19 opening 10 pumps activating 32 adding to the system 27 communicating with the computer 33, 38 guidelines 33, 38 connecting to computer 23, 24, 25 computer connections, serial 24 computer connections, USB 24 optional components, ComLink 25 connecting to your computer 24 computer connections, serial 24 computer connections, USB 24 example 24 deleting 32 getting data 32 inactivating 32 ordering 4 supported 2 R related documents 2 report generation preferences setting 15, 17 changing column order 17 choosing data 15 report settings verifying 39 report types selecting for reports 40 reporting period selecting 36 reports about 41, 42, 43 Adherence report 42 Daily Detail report 43 Dashboard and Episode Summary 41 Device Settings Snapshot 43 Logbook report 43 Sensor & Meter Overview report 42 creating 36, 37, 38, 39, 40, 41 checking for device data 37 getting new device data 38 opening the reports workspace 36 previewing 41 printing 41 saving 41 selecting devices 37 selecting report types and inclusion dates 40 selecting the reporting period 36 verifying settings 39 creating your own 43 previewing 41 printing 41 saving 41 understanding 41 reports screen overview 35 restoring the database 47 S safety 5 CareLink Pro User Guide Index 62 saving reports 41 security features of CareLink Pro 2 selecting devices for reports 37 report types and inclusion dates 40 the reporting period 36 Sensor & Meter Overview report about 42 serial connections 24 settings verifying for reports 39 software updates 45 starting the software 8 entering your password 8 logging in 8 storing a patient’s device on the system 31 inactivating 32 making active 32 supported communications devices 2 supported devices 2 ComLink 4 communication devices 4 Com-Station 4 glucose meters 3, 4 equivalent devices 4 insulin pumps 2 meter communications cable 4 supported meters 2 supported pumps 2 symbols 52 system preferences setting 11, 12, 13, 14, 15, 17 general preferences 11 open patient preferences, choosing data 14 patient lookup preferences 14 patient lookup preferences, changing column order 14 patient profile preferences 12 patient profile preferences, adding a custom field 13 patient profile preferences, changing field order 13 patient profile preferences, choosing data fields 13 report generation preferences 15 report generation preferences, changing column order 17 report generation preferences, choosing data 15 understanding 11 U understanding reports 41 Adherence report 42 Daily Detail report 43 Dashboard and Episode Summary 41 Device Settings Snapshot 43 Logbook report 43 Sensor & Meter Overview report 42 updating software 45 USB connections 24 user guide conventions 5 related documents 2 user interface Guide Me 9 navigating 8 toolbar 8 user safety contraindications 5 indications for use 5 warnings 5 V verifying report settings 39 W warnings 5 workspaces 8 T toolbar for CareLink Pro buttons 8 troubleshooting 48 CareLink Pro User Guide Index 63